Chronic Lumbosacral Radiculopathy: Impact of an Analgesic Dietary Intervention on Pain & Function

NCT02531711 | Completed

• 1 other identifier: 14-2321
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this proposed research is to assess the preliminary efficacy of dietary interventions that change dietary fats in improving clinical outcomes related to lumbar radicular pain. After a two-week baseline, consented participants are randomized to one of two diets. Key foods consistent with the diet are provided for 12 weeks along with extensive dietary counseling and support from the study-provided materials. Participants are encouraged to follow the assigned diet for another 6 weeks without provision of food. Participants complete questionnaires at baseline, randomization, and after 6 weeks, 12 weeks, and 18 weeks on the diet. They provide blood samples at randomization (2 weeks) and after 12 and 18 weeks on the diet.

Conditions

Pain

Keywords

Lumbosacral; radicular

Outcome Measures

Primary Outcomes (2)

• Oswestry Disability Index--Primary clinical outcome

  Measure of pain-specific quality of life

  12 weeks

• 17-Hydroxy Docosahexaenoic acid (DHA)--Primary biochemical outcome

  Metabolite related to dietary fatty acid intakes implicated in pain reductions

  12 weeks

Secondary Outcomes (7)

• Pain intensity

  12 weeks

• Physical activity

  12 weeks

• Sleep efficiency

  12 weeks

• Sleep quantity

  12 weeks

• Self-reported health

  12 weeks

Study Arms (2)

Diet A

EXPERIMENTAL

Dietary intervention: Dietary fats are adjusted. Key study foods and oils are provided for 12 weeks. Participants learn which foods to eat and which to avoid.

Other: Diet A

Diet B

ACTIVE COMPARATOR

Dietary intervention: This diet also adjusts dietary fats, and provides key study foods and oils for 12 weeks.

Other: Diet B

Interventions

Diet A OTHER

Experimental analgesic dietary intervention

Diet A

Diet B OTHER

Healthy comparator diet

Diet B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MRI-verified lumbosacral radiculopathy associated with herniated disc, spinal stenosis, or post-surgical fibrosis
• Pain reaching to the knee for at least 12 weeks
• Willing to complete daily diary for 20 weeks, as evidenced by completion of ≥12 of the first 14 days
• Possessing a mobile device (smart phone, tablet, laptop) capable of accessing the application and website
• Able to attend dietitian counseling sessions in Chapel Hill, NC
• Under care of a physician for LR
• Able to read and communicate in English

You may not qualify if:

• Psychosis or severe depression, anxiety, substance abuse disorder
• History of specific food allergies that would prevent adherence to study diet
• Aversion to eating fish
• Currently taking fish oil or other supplements that contain fatty acids under investigation
• Pregnancy or anticipated pregnancy
• Active treatment for a major medical illness, such as malignancy, autoimmune, immune deficiency disorder
• History of vasculitis, intracranial mass, clotting disorder (including medication-induced, e.g., warfarin)
• Cognitive dysfunction preventing informed consent
• Pending personal injury litigation, including worker's compensation
• Chronic long-term disability related to lumbosacral injury/symptoms

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North American Spine Society (NASS): collaborator
• Mayday Fund: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7200, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Carneiro, DO

  Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: August 24, 2015
• Study Start: September 1, 2015
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)